MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-02 for AXXENT 720331 manufactured by Xoft, A Subsidiary Of Icad.
[30030137]
Patient Sequence No: 1, Text Type: N, H10
[30030138]
While checking an iort (intraoperative radiation therapy) balloon for symmetry as per procedure, it was noted that the balloon was not symmetric with insertion balloon iort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5194410 |
| MDR Report Key | 5194410 |
| Date Received | 2015-11-02 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-09-30 |
| Report Date | 2015-10-07 |
| Date Reported to FDA | 2015-10-07 |
| Date Reported to Mfgr | 2015-10-07 |
| Date Added to Maude | 2015-11-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2015-11-02 |
| Catalog Number | 720331 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD |
| Manufacturer Address | 101 NICHOLSON LN SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-02 |